October 15, 2021 – Abbott Labs (Chicago, IL) has recalled two of its COVID-19 test kits over concerns about false positive results, the FDA said. The company issued a Class 1 recall, which is the most serious type of recall. It indicates that use of these devices may cause serious adverse health consequences or death. The recalled products are Abbott’s Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit.
The FDA says it warned COVID-19 test labs in September that the two Abbott kits could be faulty.
The swab samples for both tests are taken at a healthcare setting and require special laboratory processing equipment to get results. The special processing equipment uses software to automate the mixing of the chemicals for the tests.
The agency says the false positive results “may be related to the current mixing parameters for the chemicals that are combined with patient samples to detect the viruses. In some cases, the mixing parameters may cause a sample in one well of the machine’s tray to overflow into another sample well. Overflow into the wells of true negative samples that are positioned near positive samples in the tray could produce false positive results.”
The FDA noted that there have been no deaths or adverse health consequences reported from use of this test.